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U.S. Department of Health and Human Services

Class 2 Device Recall InterValve V8 Balloon Aortic Valvuloplasty Catheter

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 Class 2 Device Recall InterValve V8 Balloon Aortic Valvuloplasty Cathetersee related information
Date Initiated by FirmMarch 14, 2014
Date PostedMay 15, 2014
Recall Status1 Terminated 3 on June 16, 2014
Recall NumberZ-1621-2014
Recall Event ID 67964
510(K)NumberK133607 
Product Classification Balloon aortic valvuloplasty - Product Code OZT
ProductInterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Code Information Lot numbers: 101637, 101640
FEI Number 3010133561
Recalling Firm/
Manufacturer		 InterValve Inc
16200 State Highway 7
Unit B
Minnetonka MN 55345
Manufacturer Reason
for Recall		Leak issues were discovered through accelerated age testing.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSince this recall involved only 2 units at one site, the devices were picked up by the sales representative. There was no written communication regarding this. The site was verbally informed that there was a problem with the device that manifests itself during prepping and the devices need to be retrieved for retest.
Quantity in Commerce2
DistributionDistribution to TN only
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OZT
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